Principal Biostatistician

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Biostatistician in Germany.

As a Principal Biostatistician, you will lead the statistical planning, analysis, and oversight of multiple clinical trials, spanning Phase 1 to 4 studies. You will play a pivotal role in ensuring the robustness and regulatory compliance of trial data, contributing to protocols, Statistical Analysis Plans (SAPs), and clinical study reports. This role combines technical expertise with leadership responsibilities, mentoring statistical programmers, driving best practices, and implementing process improvements. You will collaborate closely with cross-functional teams to ensure high-quality deliverables, efficient use of resources, and alignment with global regulatory standards. Your insights will support critical decision-making, ensuring trials meet objectives and maintain scientific rigor.

Accountabilities

• Lead statistical aspects of multiple Phase 1–4 clinical trials, serving as the primary point of contact for internal teams, sponsors, and external vendors.
• Develop, review, and approve Statistical Analysis Plans, TLF shells, and study protocols, including sample size calculations and validation.
• Oversee biostatistical deliverables, ensuring compliance with ICH guidelines, CDISC standards, and regulatory requirements.
• Supervise and mentor teams of Statistical Programmers, reviewing analyses and providing guidance on data handling, TLFs, and datasets.
• Conduct unblinded analyses, support randomization planning, and participate in Interim Analyses and Independent Data Monitoring Committees.
• Ensure accuracy of trial budgets, proactively manage out-of-scope activities, and maintain financial oversight of biostatistics study teams.
• Lead internal initiatives to improve efficiency, quality, and consistency of biostatistical activities across programs.

• Master's degree or PhD in Statistics, Biostatistics, or a related field with applied clinical biostatistics experience.
• Minimum 10 years' experience in clinical trials within Biotechnology, Pharmaceutical, or CRO settings, including at least 7 years as Lead Biostatistician for Phase 1–4 studies.
• Strong expertise in drug development processes, ICH guidelines (E6(R2), E9, E9(R1)), and relevant FDA/Health Canada regulations.
• Proficiency with SAS for clinical data analysis, and solid knowledge of CDISC standards and clinical trial data structures.
• Experience with SAPs, TLFs, SDTM and ADaM datasets, and regulatory submissions.
• Demonstrated ability to lead teams, manage multiple priorities, and mentor biostatisticians and statistical programmers.
• Excellent organizational, analytical, and communication skills; fluency in English required, French is a plus.

• Flexible work schedule and home-based position.
• Opportunities for ongoing learning, development, and career progression.
• Collaborative, innovative, and supportive work environment.
• Exposure to diverse clinical trials and advanced biostatistical methodologies.
• Opportunity to lead and shape internal biostatistical practices and standards.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.

Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
It compares your profile to the job's core requirements and past success factors to determine your match score.
Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role.
Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest

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